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FDA Approves First Fully Autonomous Handheld AI Diabetic Retinopathy Screening Device

The device from Optomed and AEYE Health is aimed at primary care providers and ophthalmologists alike—and features a full subscription model with no upfront costs.

Ophthalmologists and primary care providers in the United States now have a portable, autonomous AI-powered tool capable of screening patients for sight-robbing diabetic retinopathy (DR).  

The device, officially named Aurora AEYE and developed by Finnish medical technology firm Optomed Oyj (OPTOMED.HE) with US-Israeli AEYE Health’s AEYE-DS algorithm, has received the US FDA’s first 510(k) clearance for a handheld device for the autonomous detection of DR. 

“I’m thrilled to announce that our Optomed Aurora handheld fundus camera with AEYE’s AI has received FDA clearance,” said Optomed CEO Juho Himberg. “This milestone marks a significant advancement in healthcare technology.”

The nod is based on data from two large-scale, prospective Phase III studies, which found imageability rates of 99%, with 92-93% sensitivity and 89-94% specificity. Both Optomed and AEYE Health have reported that scans with AEYE’s DR algorithm will produce results in less than 60 seconds.

The clearance comes alongside broader FDA approval for AEYE Health’s fully autonomous AEYE-DS algorithm in the United States. AEYE-DS’ clearance represents a key moment in the ophthalmic screening medical device market in the United States. Optomed’s handheld device and Topcon’s (Tokyo, Japan) deskbound NW-400 fundus camera are now the only two devices with the newly approved algorithm onboard. 

“This is the ‘holy grail’ of eye screening–fully autonomous AI, using either portable or tabletop retinal cameras and a procedure that takes a minute to perform, alongside the best-in-class diagnostic efficacy,” commented Zack Dvey-Aharon, co-founder & CEO of AEYE Health. “We believe this innovation will prevent the blindness of millions of people in the US and around the world.” 

Strategic moves by Optomed have indicated that the firm sees primary care providers as a key market for the device in the US. Both firms believe that the recently-approved Current Procedural Technology (CPT) billing code, CPT-92229, will translate to enhanced profitability for non-specialist practices that switch to the device.

Optomed has also opted for a fully subscription-based model with no upfront costs for the Aurora AEYE in a bid to further its appeal to the United States’ highly varied primary care physician landscape.

Market sentiment shows that investors are bullish on the device’s potential. Optomed’s Helsinki-listed shares surged 13.64% in the two hours between the approval announcement and the close of trading on April 30. 

Targeting the primary care segment

One potential explanation for the positive buzz and market sentiment surrounding the device’s launch in the United States may lie in the design features differentiating the Optomed Aurora AEYE and the broadening of its target market to include the much larger primary care provider segment.

The device’s purported speed and portability are among these features. But according to Laura Piila, Optomed’s vice president for devices, the AI-powered camera’s appeal doesn’t end there.

“All of the other solutions are used on a desktop camera. Two of these three require four images, but with the solution that we have with AEYE Health, you only need to take one image per eye,” she said. 

“With primary care, you’re limited with space, and they don’t have an extra room that they can dedicate to image the eye. This is a huge benefit, because you can just have the camera sitting next to the place where they take blood pressure and HbA1c,” she said. “The nurse can then just take the pictures before the patient goes off to the doctor.”

Ms. Piila believes that the device’s market potential also lies in the potential for primary care providers to meet key unmet needs in DR screening. 

“According to our healthcare data, less than 50 percent of diabetic patients actually go to get their eyes screened if they need to make a separate trip to see an OD or an MD—so there’s a large gap that needs to be closed,” she said. From concept to design, the firm has clearly positioned its device to fill this gap.

Improved economics a focal point

Optomed has also decided on an intriguing approach to sales of the device. Other manufacturers have opted to sell their devices to clinics and then charge per image report or monthly for access to the algorithm. Optomed’s pricing model for the Aurora AEYE, however, is different.

“Our model is that there is a fixed monthly fee that provides clinics unlimited use for the service. There is no upfront capital investment, and there’s always a warranty. If it breaks, we’ll just ship a new one immediately,” she said. 

Ms. Piila hopes that this low barrier to entry will entice a broader range of primary care providers with the appealing economics of such a model. The device’s pre-existing compliance with billing code CPT-92229 is also part and parcel to this strategy. 

“The subscription model will allow physicians in any scenario to generate revenue off of the device. And the reimbursement for doing AI-enabled screening is actually better than human-read screening,” she said. 

The future of screening

With the AI gold rush in full swing, Optomed has longer-term plans in place to capitalize on this trend with further diagnostic capabilities and algorithms for other offerings. 

A bevy of recent research has hinted at the promising diagnostic power of the eye for diseases from Alzheimer’s to rare cancers. Though the device is only currently approved for AEYE Health’s DR algorithm, Optomed envisions other products as screening powerhouses capable of scanning for a wide variety of ailments. 

“We are currently actively exploring opportunities with other AI teams and companies who are developing algorithms for, say, cardiovascular or neurological disorders, or other blinding diseases,” Ms. Piila said. “Our platform can integrate multiple different algorithms into the camera, and we can expand accordingly.”

For Ms. Piila, it all adds up to Optomed’s vision for an AI-powered future of disease detection and management where everybody wins. “Eventually, this device will save costs and time for the entire healthcare equation. It’s a win for the physician, for the patient, for the insurers, for everyone,” she explained. And if Optomed’s bet on this future with the Aurora EYE is successful, a win for the company behind it all will surely follow.

Editor’s Note: For more information, check out the official press release via Optomed’s here or AEYE Health’s via PR Newswire here.

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Sudeep Kumar
Sudeep Kumar
19 days ago

Finally AI has arrived in medicine